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COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH in Poland (COUGH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211171
First Posted: September 29, 2010
Last Update Posted: February 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.

Condition Intervention
Hypertension Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-I Treatment Due to couGH

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough [ Time Frame: 4 months after initiation ]

Secondary Outcome Measures:
  • General tolerability and safety of telmisartan treatment among patients, who had to stop their previous ACE-I treatment due to cough [ Time Frame: 4 months after initiation ]

Enrollment: 2498
Study Start Date: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)
Patients treated with telmisartan tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic hypertensive patients with cough caused by the ACE-i regardless any other factors.
Criteria

Inclusion Criteria: - hypertension

  • age > 18
  • ACE-I related cough Exclusion Criteria: - Current treatment with telmisartan
  • Cholestatic disorders and severe hepatic failure
  • Allergy to telmisartan
  • Pregnancy and lactation period
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211171


Locations
Poland
Many Locations, Poland
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01211171     History of Changes
Other Study ID Numbers: 14881
KL0910PL ( Other Identifier: Company internal )
15379 - KL0910SK ( Other Identifier: Company internal )
GM.2009-04-06.0017 ( Other Identifier: Company internal )
First Submitted: September 28, 2010
First Posted: September 29, 2010
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Bayer:
Cough
Telmisartan
Bradykinin
Tolerability

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action